Sondelbay

Patient Information Leaflet: Information for the User

Sondelbay 20 micrograms/80 microlitres solution for injection in pre-filled pen

teriparatide
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Sondelbay is and what it is used for
2. What you need to know before using Sondelbay
3. How to use Sondelbay
4. Possible side effects
5. How to store Sondelbay
6. Contents of the pack and other information

1. What Sondelbay is and what it is used for

Sondelbay contains the active substance teriparatide, which is used to strengthen bones and reduce the risk of fractures by stimulating bone formation.
Sondelbay is used to treat osteoporosis in adults. Osteoporosis is a disease that causes bones to become thin and fragile. This condition is particularly common in women after menopause, but it can also occur in men. Osteoporosis is also common in patients receiving corticosteroid therapy.

2. What you need to know before using Sondelbay

Do not use Sondelbay

• If you are allergic to teriparatide or to any of the other ingredients of this medicine (listed in section 6).
• If you have high levels of calcium (pre-existing hypercalcemia).
• If you have severe kidney problems.
• If you have ever been diagnosed with bone cancer or other cancers that have spread (metastasized) to the bones.
• If you have other bone diseases. Inform your doctor if you have a bone disease.
• If you have high blood levels of alkaline phosphatase of unknown origin, which may indicate Paget's disease of the bone (a disease causing abnormal bone changes). If you are unsure, ask your doctor.
• If you have undergone radiation therapy involving the bones.
• If you are pregnant or breastfeeding.

Warnings and precautions
Sondelbay may cause an increase in the amount of calcium in the blood or urine.
Talk to your doctor or pharmacist before or during treatment with Sondelbay:

• if you continuously experience nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs of too much calcium in the blood.
• if you suffer from kidney stones or have a history of kidney stones.
• if you have kidney problems (moderate renal impairment).

Some patients may experience dizziness or a rapid heartbeat after taking the first doses. During the initial doses, if you feel dizzy, inject Sondelbay in a place where you can sit or lie down.
The recommended treatment period of 24 months must not be exceeded.
Sondelbay must not be used in adults who are still growing.
Children and adolescents
Sondelbay must not be used in children and adolescents (under 18 years of age).
Other medicines and Sondelbay
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as they may occasionally interact (e.g. digoxin/digitalis, a medicine used to treat heart conditions).
Pregnancy and breastfeeding
Do not use Sondelbay if you are pregnant or breastfeeding. If you are a woman of childbearing age, you must use effective contraceptive methods during treatment with Sondelbay. If you become pregnant, Sondelbay must be discontinued. Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Some patients may experience dizziness after injection of Sondelbay. If you feel dizzy, do not drive or operate machinery until you feel better.
Sondelbay contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to use Sondelbay

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is 20 micrograms (in 80 microlitres) administered once daily by subcutaneous
injection (under-the-skin injection) in the thigh or abdomen. To help you remember to take the
medicine, inject it at the same time each day.
Inject Sondelbay every day for the length of time prescribed by your doctor. The total duration of
treatment with Sondelbay must not exceed 24 months. You must not receive more than one 24-month
treatment course in your lifetime.
Read the instructions for use on how to use the pen containing Sondelbay.
Injection needles are not included in the pen package. You may use pen needles (31G or 32G; 4 mm,
5 mm or 8 mm).
You should use the Sondelbay injection shortly after removing the pen from the refrigerator, as
described in the user manual. After use, immediately return the pen to the refrigerator. Use a new
needle for each injection and dispose of it after each use. Never store the pen with the needle
attached. Never share your Sondelbay pen with other people.
Your doctor may advise you to take Sondelbay with calcium and vitamin D. Your doctor will tell you
how much calcium and vitamin D you should take each day.
Sondelbay can be taken regardless of meals.
If you use more Sondelbay than you should
If you accidentally use more Sondelbay than you should, contact your doctor or pharmacist.
Effects expected with overdose may include nausea, vomiting, dizziness, and headache.
If you forget or are unable to take Sondelbay at your usual time, take it during the day as soon as
possible. Do not take a double dose to make up for the missed dose. Do not administer more than one
injection in the same day. Do not try to make up for a missed dose.
If you stop treatment with Sondelbay
If you are considering stopping treatment with Sondelbay, please discuss this with your doctor.
Your doctor will advise you and decide how long your treatment should continue.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The most common side effects are limb pain (frequency is very common, may affect more than 1 in 10 people) and nausea, headache, and dizziness (frequency is common).
If you feel dizzy after the injection, you should sit or lie down until you feel better. If you do not feel better, you must contact a doctor before continuing treatment. Cases of fainting have been reported in association with the use of teriparatide.
If you experience discomfort, as well as redness of the skin, pain, swelling, itching, a small localized bruise, or slight bleeding around the injection site (frequency is common), these symptoms should resolve within a few days or weeks. Otherwise, inform your doctor as soon as possible.
Some patients have experienced allergic reactions shortly after injection, including shortness of breath, facial swelling, skin rash, and chest pain (frequency is rare). In rare cases, serious and potentially life-threatening allergic reactions including anaphylaxis may occur.
Other side effects include:
Common: may affect up to 1 in 10 people

• increased cholesterol levels in the blood
• depression
• neuralgic leg pain
• feeling of weakness
• irregular heartbeat
• shortness of breath
• increased sweating
• muscle cramps
• loss of energy
• fatigue
• chest pain
• decrease in blood pressure
• heartburn (a sensation of pain or burning felt just below the breastbone)
• general malaise (vomiting)
• presence of a hernia in the duct carrying food to the stomach
• decrease in haemoglobin or number of red blood cells in the blood (anaemia)

Uncommon: may affect up to 1 in 100 people

• increased heart rate
• abnormal heart sounds
• laboured breathing
• haemorrhoids
• involuntary loss or leakage of urine
• increased need to eliminate fluids
• weight gain
• kidney stones
• muscle pain and joint pain. Some patients have experienced severe cramps or back pain requiring hospitalization.
• increased levels of calcium in the blood
• increased levels of uric acid in the blood
• increase in an enzyme called alkaline phosphatase

Rare: may affect up to 1 in 1,000 people

• reduced kidney function, including kidney impairment
• development of swelling, particularly in the hands, feet, and legs

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sondelbay

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and pen after
Exp.. The expiry date refers to the last day of that month.
Sondelbay must be stored in a refrigerator (from 2°C to 8°C). Once opened, Sondelbay may
be stored at a temperature not exceeding 25°C for up to 3 days when it cannot be kept in
the refrigerator; after this time it must be returned to the refrigerator and used within 28 days of the first
injection. Discard Sondelbay if it has been kept outside the refrigerator at a temperature up to 25°C for
more than 3 days.
Do not freeze Sondelbay. Avoid placing the pens near the freezer compartment in the refrigerator
to prevent freezing. Do not use Sondelbay if it has been frozen or is frozen.
Store in the original packaging (i.e., outer carton) to protect from light.
After 28 days from first use, each pen must be discarded, even if it is not completely
empty.
Sondelbay contains a colourless and clear solution. Do not use Sondelbay if you notice the presence of
solid particles or if the solution appears cloudy or discoloured.
Do not transfer the medicine into a syringe.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sondelbay contains

• The active substance is teriparatide. Each millilitre of injectable solution contains 250 micrograms of teriparatide. Each 80 microlitre dose contains 20 micrograms of teriparatide. A 2.4 mL pre-filled pen contains 600 micrograms of teriparatide.
• The excipients are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol and water for injections. Additionally, hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH (see section 2, “Sondelbay contains sodium”).

Description of the appearance of Sondelbay and contents of the pack
Sondelbay is a clear, colourless solution. It is supplied in a cartridge contained in a single-use pre-filled pen. Each pre-filled pen contains 2.4 mL of solution, sufficient for 28 doses.
Sondelbay is available in packs containing one pre-filled pen or three pre-filled pens. Not all pack sizes may be available.
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Centre, Moll de Barcelona s/n,
Edifici Est, 6ª Planta,
08039, Barcelona, Spain
Manufacturer
Accord Healthcare BV, Netherlands
Winthontlaan 200,
Utrecht, 3526KV, Netherlands
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,
95-200 Pabianice,
Poland
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .
This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.
User manual for the pen
Sondelbay 20 micrograms/80 microlitres solution for injection in pre-filled pen
teriparatide

Instructions for use

Before using the new Sondelbay pen, read completely both the front and
back of these Instructions for use. The reverse side of this page contains troubleshooting
guidance and additional information.
Follow the instructions carefully when using the Sondelbay pen. Also read the package leaflet
provided.
Do not share the Sondelbay pen or needles, as there is a risk of transmitting infection or
disease from one person to another.
The Sondelbay pen contains enough medicine for 28 days.
Dispose of the Sondelbay pen 28 days after the first injection, even if it is not completely
empty.
Do not administer more than one injection of Sondelbay on the same day.
Components of the Sondelbay pen

Needles not included

Check the dose counter window to

verify the number of doses remaining. The
arrow points to the number of

remaining doses. A new pen contains 28
doses.
The black dots appearing in the dose counter
window correspond to the odd numbers
Pen needles (31G or 32G; 4 mm, 5 mm or 8 mm)
indicating the remaining doses in the pen.
may be used.
Ask your doctor or pharmacist which gauge and needle length are most suitable for you.
Use a new needle for each injection.
Do not use the pen if the dose counter displays “00”, as this indicates that no doses remain.

	The Sondelbay pen does not need to be loaded.
Preparation	Prepare the injection site (thigh or abdomen) according to your doctor's or pharmacist's instructions. •Always wash your hands before each injection. •Check the pen label to make sure you are using the correct medicine. •Check the expiration date to ensure it has not passed. •Check the dose counter window to make sure there are remaining doses in the pen. A new pen contains 28 doses. Remove the pen cap. •Check that the pen and medicine cartridge are not damaged. •Check that the medicine is clear, colourless, and free from particles.
Attach a new needle	Take a new pen needle (see above). Remove the paper tab. Insert the needle straight onto the medicine cartridge. Screw the needle on firmly until tight. Remove the large needle cap and keep it aside. You will need it later to remove the needle after use.
Set the dose	Check that an empty circle symbol appears in the dose display window. Turn the dose knob clockwise with a firm motion. You will see arrows inside the dose display window. Continue turning fully until you hear a click and see a filled circle symbol in the dose display window. Release the dose knob. A filled circle with a short line above it will appear in the dose display window. This indicates that the dose has been set. Remove the small needle cap and dispose of it.

4

Inject
the dose
Gently pinch a portion of skin on the thigh or abdomen and insert the needle perpendicularly into the skin, ensuring that the dose setting window is visible. While keeping the needle in the skin, slide the injection button until it stops. This will start the injection. While keeping the needle in the skin, count slowly to 5, then remove the needle from the skin.

Wait until you see an empty circle symbol appear in the dose setting window. Now

Confirm the dose

After completing the injection and withdrawing the needle from the skin, make sure that the empty circle symbol is visible in the dose setting window.

If the empty circle symbol does not appear in the dose setting window: • Do not administer a second injection on the same day. • Re-set the pen. See Troubleshooting - Problem D.

Remove the needle

Place the large needle cap over the needle as shown above, then press to secure it in place. To prevent needlestick injuries, do not attempt to reinsert the small needle cap and do not touch the needle. Unscrew the needle from the pen by turning the large needle cap at least five full turns counterclockwise. Remove the needle and dispose of it according to your doctor’s or pharmacist’s instructions. Firmly replace the cap on the pen. Immediately return the pen to the refrigerator after use.

Troubleshooting
Problem Solution

A.	I can see air bubbles in my Sondelbay pen.	A small air bubble will not alter the dose, nor will it be harmful. You may continue to take your dose as usual.
B.	I cannot set the dose.	1. Check the dose counter window to make sure there is at least one dose remaining in the Sondelbay pen. If "00" appears in the dose counter window, this means the Sondelbay pen contains no remaining doses. The cartridge may still contain some medicine, but it cannot be injected. Use a new Sondelbay pen to administer the next dose. 2. If your Sondelbay pen contains at least one remaining dose but you are unable to set it, ensure you turn the dose setting knob clockwise until you hear a click and see a filled circle symbol in the dose setting window. Do not release the dose setting knob until you have heard the click and seen the filled circle symbol; otherwise, it will snap back to its original position. After hearing the click, release the dose setting knob. You will see a filled circle with a horizontal line above it in the dose setting window.
C.	I see a drop of medicine at the needle tip when I remove the small needle cap to administer the injection.	A small drop of medicine at the needle tip will not affect the dose. Continue to take your dose as instructed in Step 4 of the Instructions for Use.
D.	The hollow circle symbol has not appeared in the dose setting window, even after fully pressing and holding the injection button. What should I do?	You must reset the Sondelbay pen by following the steps below: 1. If you have already administered the injection, DO NOT repeat the injection a second time on the same day. 2. Remove the used needle by carefully replacing the large needle cap over the needle. Do not touch the needle. Do not attempt to reinsert the small needle cap. Unscrew the needle and dispose of it according to your doctor’s or pharmacist’s instructions. 3. Attach a new needle, remove the large needle cap, and keep it for later use. 4. Point the small needle cap toward an empty container. 5. Remove the small needle cap. Be careful, as medicine may leak out. Some medicine may have already leaked inside the small needle cap. Discard the small needle cap. 6. You should now see the hollow circle symbol in the dose setting window. If it is not visible, contact your doctor or pharmacist. 7. Replace the large needle cap on the needle. Do not touch the needle. Do not attempt to reinsert the small needle cap. Unscrew the needle and dispose of it according to your doctor’s or pharmacist’s instructions.
		8. Replace the cap on the Sondelbay pen and store the pen in the refrigerator. 9. Wash your hands. You can avoid this issue by always using a NEW needle for each injection and by fully pressing the injection button until it stops. Wait to see the hollow circle symbol, then count slowly to 5 before removing the needle from the skin.
E.	How can I tell if my Sondelbay pen is working properly?	The Sondelbay pen is designed to deliver the full dose each time it is used according to the Instructions for Use. The hollow circle symbol appears in the dose setting window once the injection is complete, indicating that the full dose of medicine has been delivered. The dose counter window displays the number of doses remaining in the pen. This number decreases by one each time an injection is administered. This also indicates that the pen is functioning correctly. Use a new needle for each injection to ensure your Sondelbay pen works properly.
F.	I cannot remove the needle from my Sondelbay pen.	1. Replace the large needle cap on the needle as shown in Step 6 on the previous page. 2. Unscrew the needle by pressing it gently against the pen and rotating it counterclockwise several times. 3. Remove the needle and dispose of it according to your doctor’s or pharmacist’s instructions. 4. If you still cannot remove the needle, ask someone to help you.

Cleaning and storage
Cleaning of the Sondelbay pen:

• Clean the outside of the Sondelbay pen with a damp cloth.
• Do not immerse the Sondelbay pen in water, nor clean it with any liquid.

Storage of the Sondelbay pen:

• Refer to the package leaflet for instructions on how to store the Sondelbay pen.

Disposal of the Sondelbay pen and needles
Disposal of the Sondelbay pen:

• Dispose of the Sondelbay pen 28 days after the first injection, even if it is not completely empty.
• Before disposing of the Sondelbay pen, ensure that the needle has been removed.
• Ask your doctor or pharmacist how to dispose of the Sondelbay pen.

Disposal of needles:

• Place used needles in a closable, dedicated sharps container or in a hard plastic container with a secure lid.
• Do not throw needles directly into household waste.
• Do not reuse the container once it is filled with needles.
• Ask your doctor or pharmacist how to properly dispose of the sharps container.
• The instructions regarding needle handling do not replace local, institutional, or healthcare personnel regulations.

Additional information:

• Read and follow the instructions provided in the package leaflet before using the product.
• Use of the Sondelbay pen by blind or visually impaired individuals is not recommended without the assistance of a person trained in the proper use of the device.
• Keep the Sondelbay pen out of sight and reach of children.
• Do not transfer the medicine into a syringe.
• Use a new needle for each injection.
• Check the label on the Sondelbay pen to ensure you have the correct medicine and that it has not expired.
• Contact your doctor or pharmacist if you notice any of the following:
• The Sondelbay pen appears damaged
• The medicine is NOT clear, colourless, and free from particles
• The Sondelbay pen contains 28 days’ supply of medicine.
• Record the date of the first injection on the outer carton of the Sondelbay pen (see the space provided: date of first use). Dispose of the Sondelbay pen 28 days after the first injection.

This user manual was last updated on